Identity
- Trade Name
- Asserachrom® HPIA EUDAMEDAsserachrom® HPIA FDA UDI
- Generic Name
- Platelet factor 4-heparin complex antibody IVD, kit, enzyme immunoassay FDA UDI
- Device Name
- Asserachrom® HPIA EUDAMED
- Model / Reference
- 00615 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03607450006155 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03607450006155 EUDAMED
- 510(k) Number
- K003767 FDA UDI
- FDA Product Code
- LCO FDA UDI
- EMDN Code
- W0103020615 COAGULATION INHIBITORS/THROMBOPHILIA MARKERS FOR HEPARIN INDUCED THROMBOCYTOPENIA TEST (HIT) EUDAMED
- GMDN Term
- Platelet factor 4-heparin complex antibody IVD, kit, enzyme immunoassay FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7695 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Asserachrom® HPIA by Diagnostica Stago — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-03607450006155 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Diagnostica Stago
- EUDAMED SRN
- FR-MF-000017089
Sources (2)
- EUDAMED 25d21a9a-516b-44f0-be7d-942c5f670061 61 fields · synced Jul 16, 2026
- FDA UDI d4083466-71fd-4fa1-a935-30d3f6d83f55 34 fields · synced May 30, 2026